JZG · Class II · 21 CFR 866.5630

FDA Product Code JZG: System, Test, Beta-2-microglobulin Immunological

Leading manufacturers include The Binding Site, Ltd., Pharmacia, Inc. and Behring Diagnostics, Inc..

53
Total
53
Cleared
124d
Avg days
1984
Since
53 devices
25–48 of 53
Cleared May 15, 1995
IL TEST BETA-2MICROGLOBULIN
K943686
Instrumentation Laboratory CO
Immunology · 290d
Cleared Feb 10, 1995
LIQUISPEX(TM) LIQUID B2M CONTROL LEVEL 1 AND 2
K946048
Clinical Controls, Inc.
Immunology · 60d
Cleared Apr 21, 1994
BECKMAN BETA-2-MICROGLOBULIN (B2M)
K940353
Beckman Instruments, Inc.
Immunology · 86d
Cleared Sep 24, 1993
IMMULITE BETA-2-MICROGLOBULIN
K931702
Diagnostic Products Corp.
Immunology · 171d
Cleared Sep 24, 1993
ADDED USE CLAIM FOR DUPONT ACA BETA-2-MICROGLOBULIN TEST PACK
K933648
Dupont Medical Products
Immunology · 59d
Cleared Sep 23, 1992
COULTER BETA-2 MICROGLOBULIN IMMUNOASSAY
K923421
Coulter Corp.
Immunology · 72d
Cleared May 28, 1992
SYN ELISA BETA 2 MICROGLOBULIN TEST KIT
K920132
Elias U.S.A., Inc.
Immunology · 136d
Cleared Mar 17, 1992
DSL ACTIVE BETA2-MICROGLOBULIN (DSL 6500)
K915508
Diagnostic Systems Laboratories, Inc.
Immunology · 99d
Cleared Mar 17, 1992
B2-MICROGLOBULIN RADIOIMMUNOASSAY
K920300
Nichols Institute
Immunology · 55d
Cleared Nov 22, 1991
ACA(R) BETA-2-MICROGLOBULIN CALIBRATOR
K914225
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 63d
Cleared Nov 07, 1991
HUMAN BETA-2 MICROGLOBIN EN-RID KIT
K913131
The Binding Site, Ltd.
Immunology · 114d
Cleared Sep 10, 1991
DSL BETA 2 MICROGLOBULIN (DSL 6200)
K911881
Diagnostic Systems Laboratories, Inc.
Microbiology · 134d
Cleared Aug 13, 1991
DSL BETA 2 MICROGLOBULIN (DSL 6100)
K912173
Diagnostic Systems Laboratories, Inc.
Immunology · 89d
Cleared Jul 24, 1991
COAT-A-COUNT BETA-2 MICROGLOBULIN IRMA
K912940
Diagnostic Products Corp.
Immunology · 19d
Cleared Apr 05, 1991
NA ALPHA 1 MICROGLOBULIN KIT
K904254
Behring Diagnostics, Inc.
Immunology · 203d
Cleared Mar 06, 1991
MILENIA BETA-2 MICROGLOBULIN
K910052
Diagnostic Products Corp.
Immunology · 58d
Cleared Sep 25, 1990
LABMASTER BETA-2-MICROGLOBULIN ELISA TEST KIT TM
K903215
Bioproducts For Science, Inc.
Chemistry · 64d
Cleared Aug 17, 1990
PHARMACIA DELFIA SYSTEM B2-MICRO
K903578
Pharmacia, Inc.
Immunology · 9d
Cleared Apr 02, 1990
BETA-2 MICROGLOBULIN EIA
K901333
Serex, Inc.
Immunology · 13d
Cleared Feb 26, 1990
AIA-PACK BMG
K900440
Tosoh Medics, Inc.
Immunology · 28d
Cleared Feb 05, 1990
PHARMACIA B2 MICRO EIA
K900449
Pharmacia, Inc.
Immunology · 6d
Cleared Oct 17, 1989
BETA2 M-TRAC BY ENZYME BEAD-BASED IMMUNOASSAY EIA
K895496
Incstar Corp.
Chemistry · 69d
Cleared Mar 16, 1989
BETA-2 MICROGLOBULIN EIA
K890694
Serex, Inc.
Immunology · 34d
Cleared Mar 09, 1989
IMX B2-MICROGLOBULIN
K890421
Abbott Laboratories
Immunology · 42d